Medical Device Quality Assurance Expert

1 day ago

Pune, Maharashtra, India beBeeQuality Full time ₹ 1,04,000 - ₹ 1,30,878
Job Title:

Design Assurance Specialist



Job Description:
  • Participate in core project teams and support quality engineering across the entire development cycle.
  • Lead product risk management, usability, reliability, and design validation efforts for new product development and design change projects.
  • Develop and implement design verification and validation plans with the project design lead.
  • Develop Critical to Quality (CTQs), design input, and output documents.
  • Qualify fixtures and validate test methods.
  • Participate in Design of Experiments (DOE) sessions, FMEA, risk management, and ensure compliance to CTQs and safety requirements.
  • Manage electronic document control and version control on all project-related documents.
  • Ensure adherence to quality systems and design assurance SOPs.
  • Lead usability, reliability, testing, verification, and validation testing internal and local vendors.
  • Provide statistical testing and reliability plans.
  • Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country-specific compliance to laws and regulations of the targeted market for distribution.
  • Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed.
  • Co-lead CAPA efforts and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues.
  • Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed quality.


Required Skills and Qualifications:
  • Bachelor's degree in engineering, preferably mechanical engineering.
  • 5-9 years of experience in medical device quality engineering.
  • Professional training and certification in quality management systems, including ISO 13485, risk management (ISO 14971), design assurance/control, verification, and validation.
  • Solid understanding of medical device regulatory requirements for Class II and III medical devices.
  • Project planning, resourcing, timelines, quality, and budgets.
  • Skilled in implementing quality tools like design of six sigma, risk management, FMEA, and FTA (Fault Tree Analysis).
  • Prefers candidates with CQE certification or similar training and experience.
  • Proficient in project management tools like MS Project.
  • Experience in GD&T.
  • Well-versed in statistical analytical techniques and software tools like MATLAB and MINITAB.


Benefits:

As a leading expert in medical device quality engineering, you will have the opportunity to make a significant impact on the development of life-changing products. You will be part of a dynamic team that values collaboration, innovation, and continuous learning.



Others:

This role offers a challenging and rewarding career path with opportunities for growth and professional development. If you are a motivated and experienced quality engineer looking for a new challenge, we encourage you to apply.

  • Quality Assurance Specialist

    6 days ago

    Pune, Maharashtra, India beBeeQualityEngineer Full time ₹ 15,44,000 - ₹ 20,16,000

    Job OverviewWe are seeking an experienced Quality Assurance Engineer to join our team. As a key member of our project team, you will be responsible for ensuring the quality of our medical devices from development to delivery.ResponsibilitiesDevelop and implement design verification and validation plans with the project design lead.Lead the development of...

  • Senior Medical Device Quality Assurance Specialist

    1 day ago

    Pune, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 12,00,000 - ₹ 15,00,000

    As a seasoned quality assurance and regulatory affairs expert, this pivotal role demands a strong understanding of quality systems and regulatory frameworks for medical devices.The ideal candidate will possess hands-on experience with regulatory submissions, post-market surveillance, and risk management.This includes coordinating with local authorities for...

  • Senior Medical Devices Specialist

    4 days ago

    Pune, Maharashtra, India beBeeRegulatory Full time ₹ 13,75,288 - ₹ 25,58,460

    Job DescriptionOur organization is seeking a seasoned professional to fill the role of Senior Device Engineer. This position requires strong technical expertise in medical devices and related industries.The selected candidate will be responsible for evaluating medical devices and ensuring compliance with regulatory standards.Required Skills and...

  • Medical Device Sales Specialist

    3 weeks ago

    Pune, Maharashtra, India Andd Jobs Full time

    Job DescriptionWe are Hiring: Business Development Manager (Medical)Interview Mode: Face to FaceJob Location: Pune & DelhiExperience: 2+ Years in Healthcare / Medical / Hearing Aids / Medical DevicesIndustry: Healthcare / Retail Clinic Chain / Hearing AidsSalary: up to INR 45,000/-Qualification: MBA / GraduateRole Overview:We seek a driven and confident...

  • Medical Device Engineer

    2 weeks ago

    Pune, Maharashtra, India Kozhnosys Full time

    Job descriptionLocation: Mangalore/Rishikesh/Bhopal Multiple openings CTC: Rs 4-5 lakhs About the Role We are seeking an experienced Engineer s to oversee hospital-based clinical trials for CanScan. The trial sites are Mangalore, Bhopal and Rishikesh. There are 3 openings, 1 in Mangalore, 1 in Bhopal and 1 in Rishikesh. The candidate should be willing to...

  • Medical Device Engineer

    2 weeks ago

    Pune, Maharashtra, India Kozhnosys Full time

    Job descriptionLocation: Mangalore/Rishikesh/BhopalMultiple openingsCTC: Rs 4-5 lakhsAbout the RoleWe are seeking an experienced Engineers to oversee hospital-based clinical trials for CanScan. The trial sites are Mangalore, Bhopal and Rishikesh. There are 3 openings, 1 in Mangalore, 1 in Bhopal and 1 in Rishikesh. The candidate should be willing to stay in...

  • Design Quality Assurance Specialist

    5 days ago

    Pune, Maharashtra, India beBeeQuality Full time ₹ 9,00,000 - ₹ 12,00,000

    Quality Engineer - Medical DevicesJob Description:As a Quality Engineer, you will be responsible for ensuring the development and manufacturing of medical devices meet the highest quality standards.Key Responsibilities:Ensure compliance with relevant regulations and standards, such as EU MDR, US FDA 510(k), and ISO 13485.Develop and implement quality...

  • Quality Assurance Expert

    2 days ago

    Pune, Maharashtra, India beBeeQuality Full time US$ 7,50,000 - US$ 15,00,000

    Job Title: Quality Assurance ExpertAbout the Role:We are seeking an experienced Quality Assurance Expert to join our team. The ideal candidate will have a strong background in software quality assurance and a passion for delivering high-quality products.Key Responsibilities:Develop and execute test plans to ensure high-quality software deliveryCollaborate...

  • Medical Device Test Engineer

    5 days ago

    Pune, Maharashtra, India beBeeQuality Full time ₹ 8,00,000 - ₹ 12,00,000

    Job Overview">Proficient in the hardware development lifecycle, encompassing conceptualization through product launch.Essential skills: process orientation, understanding of FDA and/or ISO regulations, basic knowledge thereof.Own and execute testing of MR Coils including component, coils and system level evaluations.Maintain test and tractability records...

  • Design Quality Assurance Engineer

    5 days ago

    Pune, Maharashtra, India beBeeQuality Full time

    Job Title: Design Quality Assurance EngineerWe are seeking a highly skilled Design Quality Assurance Engineer to join our team. As a key member of our design quality engineering team, you will be responsible for ensuring the quality and safety of our medical devices.Responsibilities:Ensure appropriate project and sustaining quality deliverables are created...